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Letter to NIH Committee Addressing 12/1/22 Recommendations

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December 2, 2022

NIH Research Committee

Dear Colleagues,

We write again, to comment upon your December 1st, 2022, COVID-19 convalescent plasma recommendations. For our prior letters with their dozens of physician signatories see:

Petition Open letter to NIH for revisions to CCP recommendations (ipetitions.com)

https://www.ipetitions.com/petition/a-second-open-letter-to-nih-for-revisions-to-ccp

Overall, we are pleased to see the following statement on the use of CCP for immunosuppressed patients:

Some Panel members would use CCP to treat an immunocompromised patient with significant symptoms attributable to COVID-19 and with signs of active SARS-CoV-2 replication and who is having an inadequate response to available therapies. In these cases, clinicians should attempt to obtain high-titer CCP from a vaccinated donor who recently recovered from COVID-19 likely caused by a SARS-CoV-2 variant similar to the variant causing the patient’s illness.’

We agree with this statement and are encouraged that some committee members have found that available clinical evidence supports the conclusion that CCP benefits immunosuppressed patients. We think the same way.

As we have written to you previously, the NIH recommendations for CCP are inconsistent with the NIH recommendations for monoclonal antibodies (mAbs), another antibody-based COVID-19 therapy. Consider the following:

  1. The committee has previously recommended mAbs (e.g., bebtelovimab) based on in vitro binding evidence alone without randomized clinical trial efficacy.
  2. Despite in vitro binding evidence (including high neutralizing activity) and demonstrated efficacy in randomized trials, the committee has recommended against or taken a neutral stand on CCP.

Given that specific SARS-CoV-2 antibody is the active component of both mAbs and CCP, recommendations that favored the use of mAbs but are, at best, neutral for CCP are logically inconsistent. It is difficult to understand why the committee recommended mAbs without clinical efficacy data, while failing to recommend CCP, despite considerable efficacy data ranging from observational studies to RCTs.

As you know, the Omicron subvariants have now defeated all mAbs. This leaves CCP as the only available antibody-based therapy for COVID-19. The safety of CCP is incontrovertible and it has virtually no contraindications. Moreover, it is readily available, effective in immunosuppressed (1), neutralizes the latest variants (2, 3), adapts to the rapidly-evolving virus, and is desperately needed for immunocompromised patients, particularly those with B-cell defects, who do not respond to vaccines and cannot receive Paxlovid. Your CCP recommendations are at odds with those of the IDSA , ECIL-9 (4), AABB (5), National Comprehensive Cancer Network and FDA. We urge you to revise your recommendations and align them with these important groups and take a position that is consistent with the totality of clinical efficacy data, which clearly support CCP use in immunocompromised patients.

We have sent the committee two letters in past months signed by many reputable physicians and scientists. We have offered to meet with the committee to discuss our concerns. Although we have not yet had this opportunity, we remain eager for such a discussion. This letter and previous letters document our disagreement with your recommendations. We have shared our views with colleagues, patients, and advocacy groups to register our concerns.

Again, we urge you to change your recommendations. We are aware of patients being denied CCP in some hospitals based on your recommendations. Some states, including Maryland, urge their physicians to consult your recommendations. Hence, what you say matters, and, given the ongoing crisis, we worry that your current recommendations are hindering the care of immunosuppressed patients. We advise you not to wait another six-month period and to revise your recommendations around convalescent plasma as soon as possible.

Sincerely,

Leadership of COVID-19 Convalescent Plasma Project (ccpp19.org)

Arturo Casadevall MD, PhD (CCPP19.org Chair)

Chair, Molecular Microbiology & Immunology

Alfred & Jill Sommer Professor and Chair

Bloomberg Distinguished Professor

Professor, Department of Molecular Microbiology and Medicine

Johns Hopkins School of Public Health and School of Medicine

Michael Joyner, MD

Caywood Professor of Anesthesiology

Vice Chair (Research) Department of Anesthesiology & Perioperative Medicine

Mayo Clinic

Brenda J. Grossman, MD, MPH

Professor, Pathology & Immunology
Professor of Medicine

Medical Director, Transfusion Medicine Services

Washington University School of Medicine

Jeffrey P. Henderson, MD, PhD

Associate Professor of Medicine and Molecular Microbiology

Division of Infectious Diseases

Washington University School of Medicine

Nigel Paneth MD MPH

University Distinguished Professor, Emeritus

Departments of Epidemiology & Biostatistics and Pediatrics & Human Development
Michigan State University

Liise-anne Pirofski MD

Selma and Dr. Jacques Mitrani Chair in Biomedical Research

Professor, Medicine, Microbiology, and Immunology

Chief, Division of Infectious Diseases

Albert Einstein College of Medicine and Montefiore Medical Center

Shmuel Shoham MD

Professor

Department of Medicine

Johns Hopkins School of Medicine

Other Signatories

Matthew Abinante, DO, MPH

Principal Investigator

Ascada Research

Jennifer Alexander-Brett, MD, PhD

Associate Professor of Medicine

Division of Pulmonary and Critical Care Medicine

Washington University, USA

David Andes, MD
William A. Craig Professor

Chief, Division of Infectious Diseases

Director, Wisconsin Antimicrobial Discovery and Development Center

Department of Medicine

Department of Medical Microbiology and Immunology

School of Medicine and Public Health and School of Pharmacy

University of Wisconsin-Madison

Shweta Anjan, MD

Assistant Professor of Clinical Medicine

Associate Program Director, Transplant Infectious Disease Fellowship

Division of Infectious Diseases

Transplant and Immunocompromised Host Service

Jackson Memorial Hospital

Miami Transplant Institute

University of Miami Miller School of Medicine

Paul Auwaerter, MD

Clinical Director, Division of Infectious Diseases

Professor of Medicine

Johns Hopkins School of Medicine

(IDSA President, 2018)

Robin K. Avery MD, FIDSA, FAST

Professor of Medicine, Division of Infectious Diseases

Transplant and Oncology Infectious Diseases Program

Johns Hopkins

Katharine Bar, MD

Assistant Professor of Medicine

Department of Medicine

University of Pennsylvania

Philadelphia, PA

Martin J. Blaser, M.D.

Henry Rutgers Chair of the Human Microbiome

Professor of Medicine and Pathology & Laboratory Medicine – RWJMS

Director, Center for Advanced Biotechnology and Medicine

Rutgers University

Editor, Principles and Practice of Infectious Diseases

(IDSA President 2006)

Evan Bloch MBChB, MS

Associate Director, Transfusion Medicine Division

Associate Professor of Pathology

Johns Hopkins School of Medicine

Baltimore, MD

Robert Bonomo, MD

Professor of Medicine

Case Western Reserve University

David Boulware, MD, MPH

Professor of Medicine,

Division of Infectious Diseases and International Medicine

University of Minnesota

Patrick Broderick, MD

Nuvance Health

Danbury Hospital

Connecticut

Michael P. Busch, M.D., Ph.D.

Director Emeritus, Vitalant Research Institute

Vice President for Research and Scientific Programs, Vitalant

Professor of Laboratory Medicine, UCSF

Claudia S. Cohn, MD, PhD

Chief Medical Officer, Association for the Advancement of Blood and Biotherapies (AABB)

Professor of Laboratory Medicine and Pathology

University of Minnesota Medical School

MarieElena Cordisco MA, NP-C, APRN

Associate Vice President Clinical Trials

Research and Innovation

Nuvance Health

Dan Cruser MD

Nuvance Health

Vassar Brothers Medical Center,

Poughkeepsie NY

Carlos Del Rio, MD

Executive Associate Dean, Emory School of Medicine & Grady Health System

Distinguished Professor, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine

Professor, Hubert Department of Global Health, Rollins School of Public Health

Co-Director, Emory Center for AIDS Research

Co-PI, Emory-CDC HIV Clinical Trials Unit and the Emory Vaccine and Treatment Evaluation Unit

President IDSA

Yuriko Fukuta, MD, PhD

Assistant Professor

Department of Medicine

Section of Infectious Diseases

Baylor College of Medicine

Houston, Texas, United States

Amita Gupta, MD, MHS, FIDSA

Chief, Division of Infectious Diseases

Professor of Medicine and International Health

Faculty co-Chair, Johns Hopkins India Institute

Deputy Director, Center for Clinical Global Health Education

Principal Investigator, Johns Hopkins University Baltimore India Clinical Trials Unit

US Chair, DBT-NIH RePORT India TB research consortium

Advisor, NIH/NIAID Council

Johns Hopkins University

Sonya Heath MD

Department of Medicine,

Division of Infectious Diseases,

University of Alabama at Birmingham,

Birmingham, AL

Moises A. Huaman, MD MSc

Associate Professor of Medicine

Co-PI, Infectious Diseases Research Unit

University of Cincinnati College of Medicine

Seble G. Kassaye MD

Associate professor of Medicine

Georgetown University Medical Center

Georgetown University

Justin Juskewitch MD PhD

Division of Transfusion Medicine

Mayo Clinic, Rochester, MN

Eleftherios Mylonakis, M.D., Ph.D., FIDSA, FAAM

Charles C.J. Carpenter Professor of Infectious Disease

Chief, Infectious Diseases Division

Director, COBRE Center for Antimicrobial Resistance and Therapeutic Discovery

Rhode Island Hospital and The Miriam Hospital

Kevin Oei, DO DNBPAS

Principal Investigator

Ascada Research

Fullerton, CA

Max O'Donnell MD, MPH

Florence Irving Associate Professor of Medicine

Division of Pulmonary, Allergy, and Critical Care Medicine, & Department of Epidemiology

Columbia University Medical Center

Ferric Fang, MD

Professor of Laboratory Medicine

University of Washington

Daniele Focosi, MD, PhD, MS
North-Western Tuscany Blood Bank
Building 2k, First floor
Azienda Ospedaliero-Universitaria Pisana
via Paradisa 2 - 56124 Pisa – Italy

Donald Forthal, MD

Professor of Medicine and Molecular Biology and Biochemistry

Center for Virus Research

Chief, Division of Infectious Diseases

University of California, Irvine School of Medicine

Vance Fowler, MD

Florence McAlister Distinguished Professor of Medicine

Professor of Medicine

Duke University

Massimo Franchini, MD

Chair, Department of Hematology and Transfusion Medicine, Carlo Poma Hospital,

Mantua, Italy

Neil Gaffin, MD

Ridgewood Infectious Disease Associates

947 Linwood Avenue, Suite 2e
Ridgewood, NJ 07450

Kelly Gebo, MD, MPH

Professor

Department of Medicine

Johns Hopkins University

Jonathan M. Gerber, MD

Professor of Medicine

Chief, Hematology/Oncology

Medical Director, Cancer Center

Eleanor Eustis Farrington Chair in Cancer Research

University of Massachusetts Chan Medical School & UMass Memorial Health

Worcester, MA

Anne Gershon, MD

Professor of Pediatrics

Columbia University

(IDSA President 2009)

Neil S. Greenspan, MD, PhD

Professor of Pathology

Case Western Reserve University

Jean M. Hammel, MD, FACEP

Vice Chair, Department of Emergency Medicine

Associate Chief of Staff

Norwalk Hospital / Nuvance Health

William Hartman, MD, PhD

Associate Professor

Department of Anesthesiology

University of Wisconsin

Dimitrios P. Kontoyiannis, MD, ScD, PhD (Hon), FACP, FIDSA, FECMM, FAAM, FAAAS

Robert C Hickey Chair in Clinical Care

Deputy Head, Division of Internal Medicine

MD Anderson Cancer Center

Adam C. Levine, MD, MPH, FACEP

Professor of Emergency Medicine and Health Services, Policy & Practice

Chief, Division of Global Emergency Medicine

Brown University Alpert Medical School and School of Public Health

W. Ian Lipkin, MD

John Snow Professor of Epidemiology and Director

Center for Infection and Immunity

Mailman School of Public Health

Professor of Pathology and Neurology

College of Physicians & Surgeons

Columbia University

Barry Meisenberg MD

Chair Department of Medicine

Medical Director Research Institute

Luminis Health

Annapolis, MD

Ryan A. Metcalf, MD, CQA(ASQ)

Section Chief, Transfusion Medicine | Medical Director, Blood Bank

Associate Professor | Inpatient Chief Value Officer

Department of Pathology

University of Utah Health | ARUP Laboratories

James M. Musser, MD, PhD

Chair, Department of Pathology & Genomic Medicine

Fondren Presidential Distinguished Chair, Research Institute

Professor of Pathology and Genomic Medicine, Academic Institute

Director, Center for Molecular & Translational Human Infectious Diseases Research

Houston Methodist

Josh Nosanchuk, MD

Senior Associate Dean

Professor, Medicine, Microbiology and Immunology

Albert Einstein College of Medicine

Monica B. Pagano MD

Associate Professor, Laboratory Medicine and Pathology

Medical Director, Transfusion Services

Head, Transfusion Medicine Division

University of Washington

Seattle Washington

Bela Patel, M.D., FCCP, FCCM

Graham Distinguished University Chair

Vice Dean of Healthcare Quality

Vice Chair of Medicine for Memorial Hermann

Division Director of Critical Care Medicine

Interim Director of Pulmonary and Sleep Medicine

Distinguished Teaching Professor of The University of Texas System

Professor of Medicine

John Perfect, MD

James B. Duke Distinguished Professor of Medicine

Professor of Medicine

Chief, Division of Infectious Diseases

Professor in Molecular Genetics and Microbiology

Duke University

Jay S. Raval, MD

Associate Professor and Director, Transfusion Medicine & Therapeutic Pathology

University of New Mexico

Rita A. Reik, MD

OneBlood

10100 Dr. Martin Luther King Jr. St. N.

St. Petersburg, FL 33716

Michael Roth

Managing Director

The Bliss Group

Eric Salazar, MD, PhD

Associate Professor

UT Health San Antonio

Cynthia L. Sears, M.D.

Bloomberg Kimmel Professor of Immunotherapy

Professor of Medicine, Oncology & Molecular Microbiology and Immunology

Johns Hopkins University School of Medicine

(IDSA President 2019)

Jonathon (Jack) Senefeld, Ph.D.

Assistant Professor

Department of Anesthesiology and Perioperative Medicine

Mayo Clinic Rochester

Aarthi Shenoy, MD

Hematology/Oncology

Washington Hospital Center

Samuel Silverstein, MD

Emeritus John C. Dalton Professor of Physiology & Cellular Biophysics, and Professor of Medicine

Columbia University

David Sullivan MD

Professor

Department of Microbiology and Immunology

Johns Hopkins School of Public Health

Baltimore, MD

Michael Thompson, MD, PhD

Vice President of Clinical Partnerships at Tempus Labs

Milwaukee, WI

Aaron Tobian, MD, PhD

Professor of Pathology, Medicine and Epidemiology

Director, Transfusion Medicine Division

Deputy Director for Clinical Affairs, Department of Pathology

School of Medicine

Bloomberg School of Public Health

The Johns Hopkins University

Baltimore, MD

David van Duin, MD, PhD

Professor of Medicine

Director, Immunocompromised Host Infectious Diseases Section

Department of Medicine

University of North Carolina

Chapel Hill, NC

Jeremy L. Warner MD, MS

Associate Professor (appointment pending) of Medicine and Public Health at Brown University

Member of the Population Sciences Program, Legorreta Cancer Center at Brown University

Adjunct Associate Professor of Medicine at Vanderbilt University

Richard Whitley MD

Distinguished Professor of Pediatrics

University of Alabama

(IDSA President 2010)

Martin S. Zand, MD, PhD

Dean’s Professor of Medicine and Public Health Sciences

Senior Associate Dean for Clinical Research

Co-Director, Clinical and Translational Science Institute

University of Rochester Medical Center

1. Senefeld JW, Franchini M, Mengoli C, Cruciani M, Zani M, Gorman EK, Focosi D, Casadevall A, Joyner MJ.2022. COVID-19 convalescent plasma for the treatment of immunocompromised patients: a systematic review. medRxiv doi:10.1101/2022.08.03.22278359:2022.08.03.22278359.

2. Sullivan DJ, Franchini M, Senefeld JW, Joyner MJ, Casadevall A, Focosi D.2022. Plasma after both SARS-CoV-2 boosted vaccination and COVID-19 potently neutralizes BQ.1.1 and XBB.1. bioRxiv doi:10.1101/2022.11.25.517977:2022.11.25.517977.

3. Sullivan DJ, Franchini M, Joyner MJ, Casadevall A, Focosi D.2022. Analysis of anti-SARS-CoV-2 Omicron-neutralizing antibody titers in different vaccinated and unvaccinated convalescent plasma sources. Nat Commun 13:6478.

4. Cesaro S, Ljungman P, Mikulska M, Hirsch HH, von Lilienfeld-Toal M, Cordonnier C, Meylan S, Mehra V, Styczynski J, Marchesi F, Besson C, Baldanti F, Masculano RC, Beutel G, Einsele H, Azoulay E, Maertens J, de la Camara R, Pagano L.2022. Recommendations for the management of COVID-19 in patients with haematological malignancies or haematopoietic cell transplantation, from the 2021 European Conference on Infections in Leukaemia (ECIL 9). Leukemia doi:10.1038/s41375-022-01578-1.

5. Estcourt LJ, Cohn CS, Pagano MB, Iannizzi C, Kreuzberger N, Skoetz N, Allen ES, Bloch EM, Beaudoin G, Casadevall A, Devine DV, Foroutan F, Gniadek TJ, Goel R, Gorlin J, Grossman BJ, Joyner MJ, Metcalf RA, Raval JS, Rice TW, Shaz BH, Vassallo RR, Winters JL, Tobian AAR.2022. Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma. Ann Intern Med 175:1310-1321.

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